The general objective of this proposal is to develop a user-friendly organizational framework and computational tool for integrating various lines of evidence in a quantitative weight of evidence (QWOE) approach to aid regulatory decision-making for bioaccumulation assessment. To satisfy this general objective:
- A tool that brings together measured data (e.g., chemical properties, in vivo and in vitro bioaccumulation and toxicokinetics) and modelled data (e.g., chemical properties, in vivo and in vitro bioaccumulation and toxicokinetics data) in a quantitative framework for a suite of bioaccumulation assessment endpoints will be developed.
- The development of the tool will consider suggestions and recommendations from stakeholders (industry, academic and regulatory scientists) throughout the project.
- The proposed “Bioaccumulation Assessment Tool (BAT Ver.1.0)” will be publicly and freely available and it will be accompanied by supporting documentation (e.g., tool description and user’s guide).
- The tool will provide the capacity for transparency and consistency in bioaccumulation assessment.
- When necessary, the organizational framework will also provide pragmatic and strategic guidance for integrated (tiered) testing strategies (i.e., possible generation of additional lines of evidence) to address uncertainty and foster confidence in the decision-making process.
Within the scope of the project, the tool will bring together the state of the science for bioaccumulation assessment. Once established The BAT Ver.1.0 will continue to evolve with the emerging science (i.e., improved mechanistic understanding of bioaccumulation processes and new data streams) and from practical experience in its application and evaluation.
The development of a user-friendly Excel spreadsheet tool and complementary user-guidance is proposed. The proposed tool provides a much needed and unique quantitative framework to organize and integrate various lines of measured and predicted bioaccumulation information (i.e., measured BCFs, predicted BCFs, measured BMFs, in vitro biotransformation rates, QSAR predictions for biotransformation rate constants, absorption efficiency, etc.) for bioaccumulation assessment guidance based on the state-of-the-science. The framework provides the opportunity for transparency and consistency in the interpretation of the results to guide sound, scientifically defensible decision-making. The proposed project topic fits under the umbrella of the PBT Expert Group long-term approach development issues list.
The proposed BAT is conceptually similar to the OECD POV and LRTP Screening Tool in that it is intended to facilitate consistent and comparable assessments of a hazard property, directly aligned to current regulatory criteria and practice (i.e., nB, B, vB). Accordingly, the implementation of the BAT could have significant impact on bioaccumulation decision-making under REACH and in other regulatory programs.
Jon Arnot, James Armitage, Karen Foster, Liisa Toose, Michelle Embry. 2017. The Bioaccumulation Assessment Tool: An Organizational Framework for Bioaccumulation Assessment. Poster accepted for SETAC Brussels.
Jon Arnot, James Armitage, Karen Foster, Liisa Toose. 2016. The Bioaccumulation Assessment Tool: An Organizational Framework for Bioaccumulation Assessment. Poster presented at SETAC Orlando.
Jon Arnot, James Armitage. 2016. The Bioaccumulation Assessment Tool: An Organizational Framework for Bioaccumulation Assessment. Poster at SETAC Nantes.